Consent to the Distribution of a New Medicine Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto: Schedule Product: Isopto Fenicol. Active Ingredient(s): Chloramphenicol 5 mg/mL. Dosage Form: Eye drops, solution. NZ Sponsor: Pacific Pharmaceuticals Limited. Manufacturer(s): Alcon Couvreur SA, Puurs, Belgium. Product: Primelle. Active Ingredient(s): Oestradiol 2 mg. Norethisterone acetate 1 mg. Dosage Form: Film coated tablet. NZ Sponsor: Schering (NZ) Limited. Manufacturer(s): Schering AG, Wedding Plant, Berlin, Germany. Product: Sifrol. Active Ingredient(s): Pramipexole dihydrochloride (monohydrate) 1 mg. Dosage Form: Tablet. NZ Sponsor: Boehringer Ingelheim (NZ) Limited. Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany. Pharmacia & Upjohn Caribe Inc, Arecibo, Puerto Rico. Product: Sifrol. Active Ingredient(s): Pramipexole dihydrochloride (monohydrate) 1.25 mg. Dosage Form: Tablet. NZ Sponsor: Boehringer Ingelheim (NZ) Limited. Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany. Pharmacia & Upjohn Caribe Inc, Arecibo2, Puerto Rico. Product: Sifrol. Active Ingredient(s): Pramipexole dihydrochloride (monohydrate) 1.5 mg. Dosage Form: Tablet. NZ Sponsor: Boehringer Ingelheim (NZ) Limited. Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany. Pharmacia & Upjohn Caribe Inc, Arecibo, Puerto Rico. Product: Sifrol. Active Ingredient(s): Pramipexole dihydrochloride (monohydrate) 125 g. Dosage Form: Tablet. NZ Sponsor: Boehringer Ingelheim (NZ) Limited. Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany. Pharmacia & Upjohn Caribe Inc, Arecibo, Puerto Rico. Product: Sifrol. Active Ingredient(s): Pramipexole dihydrochloride (monohydrate) 250 g. Dosage Form: Tablet. NZ Sponsor: Boehringer Ingelheim (NZ) Limited. Manufacturer(s): Boehringer Ingelheim Pharma KG, Ingelheim am Rhein, Germany. Pharmacia & Upjohn Caribe Inc, Arecibo, Puerto Rico. Dated this 18th day of August 1999. G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).